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What we do

Boehringer Ingelheim BioXcellence™ offers the full spectrum of services for late-stage products – with a hard-won reputation as a reliable partner accompanying you throughout the lifecycle of your product. We can help you to turn biologic innovation into commercial reality.

Trusted partners in…

 

Mammalian Cell Cultures

  • Fast and tailored transfers

  • Upstream and downstream processing

  • Launch preparation and regulatory support

  • Clinical and commercial supply

  • GMP facilities licensed by EMA, FDA & MHLW

  • All analytic capabilities inhouse

  • GMP batch release testing

  • Manufacturing of Fab fragment, Fc fusion proteins, TandAb, Ig DART, and further complex biologics like bi- or multispecific mAbs

 

Microbial Technologies

  • Clinical and commercial supply

  • Refolding, large-scale HPLC and chemical
    modifications to prolong molecule half-life

  • Several plasmid-based gene expression
    systems for E. coli, yeast and Pseudomonas

  • Genetic engineering

  • Cell line and strain development

  • Fast and tailored project transfers

  • Process and analytical development

  • Upstream and downstream processing

  • Large-scale GMP facilities licensed by EMA, FDA & MHLW

  • GMP batch release testing

  • Manufacturing of Fab fragment, peptide
    hormones, plasmid DNA, scaffolds,
    recombinant proteins, enzymes and
    recombinant vaccines

 

Aseptic Filling

  • Clinical and commercial capacities and
    technology for vials

  • Formulations for liquids and lyophilizates vials

  • Flexible filling volumes for clinical and
    commercial supply

  • Manual and automated visual inspections

  • Globally licensed (e.g. FDA, EMA, PMDA,
    ANVISA) multi product facilities